BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2091653 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-00580
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT REC'D AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT IS EXPERIENCING RIB PAIN. THE REPORTED DISCOMFORT IS SAID TO BE PRESENT REGARDLESS OF THE STIMULATION'S FUNCTION. MEDICATION WAS PRESCRIBED IN AN EFFORT TO ALLEVIATE THE REPORTED PAIN. F/U ON THIS MATTER FOUND THAT THE PT IS VIRTUALLY PAIN FREE AS THE REPORTED DISCOMFORT WAS RESOLVED WITH THE USE OF THE PRESCRIBED MEDICATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3228 3296508

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: